On March 22, 2023 SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies, reported full year 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, MAR 22, 2023, View Source [SID1234629205]).
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"The team is focused on our key initiatives of advancing our SQZ eAPC and SQZ AAC programs," said Howard Bernstein, M.D., Ph.D., Interim Chief Executive Officer and Member of the Board of Directors. "After the restructuring in December, we made important changes to align our talent to fully support our clinical development efforts—we are now primed to deliver on multiple clinical milestones over the next 12 months. We are encouraged by the observation of a confirmed complete response in the first patient in the lowest-dose cohort our AAC trial and have therefore decided to continue the AAC trial. We remain focused on optimizing the potential of our eAPC and AAC platforms to meet the significant unmet medical needs of patients with HPV16+ tumors. We look forward to data from both these programs later in the year."
2022 Full Year and Recent Portfolio Updates
Clinical Programs:
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology
Received FDA fast track designation for the treatment of HPV16+ tumors
Stable disease observed in two out of four evaluable patients in eAPC Phase 1/2 trial including a pronounced pharmacodynamic response in a patient with prolonged stable disease
Interim results from the ongoing SQZ eAPC Phase 1/2 trial showed favorable safety data and the investigational therapy was generally well tolerated
Strong enrollment rate on track to report clinical data for the highest-dose monotherapy cohort in the middle of 2023
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology
A confirmed complete response (CR), by RECIST 1.1 criteria, was observed in the first patient in the lowest-dose cohort of the SQZ-AAC-HPV-101 Phase 1 clinical trial for HPV16+ solid tumors
In light of the response, the company has decided to continue to enroll patients in the SQZ-AAC-HPV-101 clinical trial; Two additional patients have been dosed in the lowest-dose cohort and the dose-limiting toxicity (DLT) period has been completed
The recommendation of the Study Safety Committee is for the company to move directly to enrolling patients in the highest-dose cohort
Initial clinical data from the highest-dose cohort is anticipated in the fourth quarter of 2023
Published comprehensive preclinical research in Frontiers in Immunology
Earlier Stage Programs:
The company will continue to explore partnerships and collaborations for its earlier stage assets and programs, including SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance
2022 Full Year Financial Highlights
Revenue for the year ended December 31, 2022, was $21.5 million compared to $27.1 million for the year ended December 31, 2021
Research and development expenses for the year ended December 31, 2022, were $71.0 million compared to $70.1 million for the year ended December 31, 2021
General and administrative expenses for the year ended December 31, 2022, were $26.3 million compared to $25.7 million for the year ended December 31, 2021
Restructuring charges for the year ended December 31, 2022, were $4.9 million, primarily composed of $4.1 million in one-time termination benefits payable to employees included in the 60% workforce reduction, and $0.8 million in non-cash restructuring charges.
Net loss for the year ended December 31, 2022, was $79.5 million, compared to $68.7 million for the year ended December 31, 2021
As of December 31, 2022, the Company had cash and cash equivalents of $63.7 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into 2024
An updated investor presentation is available on the Events & Presentations page within the investor relations section of the company’s corporate website, investors.sqzbiotech.com. Based on guidance from the SEC, investors should note that the company may utilize its corporate website to post updated corporate and scientific presentations. It is possible that the information posted there could be deemed to be material information.